Evaluation of the Bio-Rad Geenius HIV 1/2 Assay as Part of a Confirmatory HIV Testing Strategy for Quebec, Canada: Comparison with Western Blot and Inno-Lia Assays

J Clin Microbiol. 2019 May 24;57(6):e01398-18. doi: 10.1128/JCM.01398-18. Print 2019 Jun.

Abstract

The rapid confirmatory Bio-Rad Geenius HIV 1/2 assay was evaluated as an alternative to the HIV-1 Western blot (WB) confirmatory assay. A total of 370 retrospective samples collected from 356 patients were tested. Sensitivity of the Geenius assay to detect HIV-1 and HIV-2 infections was 100% and 97%, respectively, and that of the WB assay was 86% and 39%, respectively. Geenius reduced the number of indeterminate results by 85% and exhibited a differentiation capacity for HIV-1 and HIV-2 of 100% and 89%, respectively. Three of 10 patients presenting with an early HIV infection (1 to 2 weeks before seroconversion by WB) were positive using Geenius. None of the HIV-negative samples were positive using Geenius or WB. However, 7% and 10% of them were indeterminate with Geenius and WB, respectively, leading to a specificity rate of 93% for Geenius and 90% for WB. Ninety cadaveric samples (54 negative, 23 HIV-1 positive, and 3 HIV-1 indeterminate) were tested with Geenius, leading to a sensitivity of 100%, a specificity of 96%, and an indeterminate rate of 4%. Our results indicate that the Bio-Rad Geenius HIV 1/2 rapid test exhibits better sensitivity to detect HIV-1 infections and better performance than WB to confirm and differentiate between HIV-1 and HIV-2 infections. The performance of this new confirmatory assay to detect early infections, to reduce the rate of indeterminate status, and to confirm HIV-1 infection in cadaveric blood samples makes Geenius a potent reliable alternative to the WB.

Keywords: Geenius; HIV; cadaveric; confirmation.

MeSH terms

  • Adolescent
  • Adult
  • Blotting, Western* / methods
  • Blotting, Western* / standards
  • Child
  • Female
  • HIV Infections / diagnosis*
  • HIV Infections / epidemiology
  • HIV Infections / virology*
  • HIV-1* / metabolism
  • HIV-2* / metabolism
  • Humans
  • Male
  • Quebec
  • Reagent Kits, Diagnostic* / standards
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Viral Proteins / metabolism
  • Young Adult

Substances

  • Reagent Kits, Diagnostic
  • Viral Proteins